clonidine has been researched along with Fecal Incontinence in 5 studies
Clonidine: An imidazoline sympatholytic agent that stimulates ALPHA-2 ADRENERGIC RECEPTORS and central IMIDAZOLINE RECEPTORS. It is commonly used in the management of HYPERTENSION.
clonidine (amino form) : A clonidine that is 4,5-dihydro-1H-imidazol-2-amine in which one of the amino hydrogens is replaced by a 2,6-dichlorophenyl group.
Fecal Incontinence: Failure of voluntary control of the anal sphincters, with involuntary passage of feces and flatus.
| Excerpt | Relevance | Reference |
|---|---|---|
| "Fecal incontinence severity was assessed with daily bowel diaries and periodic questionnaires (fecal incontinence severity score [FISS], FIQOL, 36-Item Short Form Health Survey [SF-36], and hospital anxiety and depression scales) for 4 weeks before and during double-blind randomization to placebo or clonidine in 44 women with FI." | 5.22 | Validating endpoints for therapeutic trials in fecal incontinence. ( Bharucha, AE; Noelting, J; Zinsmeister, AR, 2016) |
| Timeframe | Studies, this research(%) | All Research% |
|---|---|---|
| pre-1990 | 0 (0.00) | 18.7374 |
| 1990's | 0 (0.00) | 18.2507 |
| 2000's | 0 (0.00) | 29.6817 |
| 2010's | 5 (100.00) | 24.3611 |
| 2020's | 0 (0.00) | 2.80 |
| Authors | Studies |
|---|---|
| Sharma, M | 1 |
| Feuerhak, K | 1 |
| Zinsmeister, AR | 4 |
| Bharucha, AE | 4 |
| Fletcher, JG | 1 |
| Camilleri, M | 1 |
| Edge, J | 1 |
| Carlson, P | 1 |
| Wald, A | 1 |
| Noelting, J | 1 |
| Seide, BM | 1 |
| Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
|---|---|---|---|---|---|---|---|
| A Placebo-Controlled Study of Clonidine for Fecal Incontinence.[NCT00884832] | Phase 2 | 44 participants (Actual) | Interventional | 2008-10-31 | Completed | ||
| Treatment of Diarrhea-Associated Fecal Incontinence With Eluxadoline[NCT03489265] | Phase 2 | 0 participants (Actual) | Interventional | 2019-04-30 | Withdrawn (stopped due to Difficult to recruit severely affected patients with fecal incontinence) | ||
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] | |||||||
"Scores were computed from a pre-treatment questionnaire, the Fecal Incontinence Quality of Life Scale. This scale is composed of a total of 29 items; these items form four scales: Lifestyle (10 items) Coping/Behavior (9 items), Depression/Self Perception (7 items), and Embarrassment (3 items).~Scales range from 1 to 4; with a 1 indicating a lower functional status of quality of life. Scales scores are the average (mean) response to all items in the scale (that is, add the responses to all questions in a scale together and then divide by the number of items in the scale, adjusting for missing values)." (NCT00884832)
Timeframe: 4 weeks baseline
| Intervention | units on a scale (Mean) | |||
|---|---|---|---|---|
| Lifestyle score | Coping score | Depression score | Embarrassment score | |
| Oral Clonidine | 2.8 | 1.8 | 3.2 | 2.2 |
| Oral Placebo | 2.3 | 1.6 | 2.9 | 2.3 |
"Scores were computed from a post-treatment questionnaire, the Fecal Incontinence Quality of Life Scale. This scale is composed of a total of 29 items; these items form four scales: Lifestyle (10 items) Coping/Behavior (9 items), Depression/Self Perception (7 items), and Embarrassment (3 items).~Scales range from 1 to 4; with a 1 indicating a lower functional status of quality of life. Scales scores are the average (mean) response to all items in the scale (that is, add the responses to all questions in a scale together and then divide by the number of items in the scale, adjusting for missing values)." (NCT00884832)
Timeframe: after 4 weeks treatment
| Intervention | units on a scale (Mean) | |||
|---|---|---|---|---|
| Lifestyle score | Coping score | Depression score | Embarrassment score | |
| Oral Clonidine | 3.1 | 2.3 | 3.5 | 2.8 |
| Oral Placebo | 2.7 | 2.1 | 3.2 | 2.5 |
The FICA severity scale has 4 items (frequency, type, amount of leakage, and presence of urgency) and is used to rate the severity of fecal incontinence. The parameter was computed from values in the weekly diaries. The FICA score can range from 1 to 13. Symptom severity scores of 1-6, 7-10, and 11-13 are categorized as mild, moderate, and severe, respectively. Scores were averaged over the 4 week baseline period and the 4 week treatment periods. (NCT00884832)
Timeframe: 4 weeks baseline, 4 weeks treatment
| Intervention | units on a scale (Mean) | |
|---|---|---|
| 4 weeks baseline | 4 weeks treatment | |
| Oral Clonidine | 8.1 | 6.5 |
| Oral Placebo | 9.1 | 7.6 |
Values were averaged over 4 week baseline and 4 week treatment periods. (NCT00884832)
Timeframe: 4 weeks baseline, 4 weeks treatment
| Intervention | days (Mean) | |
|---|---|---|
| 4 weeks baseline | 4 weeks treatment | |
| Oral Clonidine | 13 | 8 |
| Oral Placebo | 16 | 11 |
Values were averaged over 4 week baseline and 4 week treatment periods. (NCT00884832)
Timeframe: 4 weeks baseline, 4 weeks treatment
| Intervention | number of episodes (Mean) | |
|---|---|---|
| 4 weeks baseline | 4 weeks treatment | |
| Oral Clonidine | 20 | 12 |
| Oral Placebo | 31 | 19 |
Values were averaged over 4 week baseline and 4 week treatment periods. (NCT00884832)
Timeframe: 4 weeks baseline, 4 weeks treatment
| Intervention | percentage of bowel movements (Mean) | |
|---|---|---|
| 4 weeks baseline | 4 weeks treatment | |
| Oral Clonidine | 31 | 24 |
| Oral Placebo | 40 | 27 |
The Fecal Incontinence Severity Index was used to compute the severity of fecal incontinence (FI). It is a validated 4-item scale used to assess the frequency of 4 different types of FI (gas, mucus, liquid stool, solid stool). The subject responses are weighted and summed for the 4 types of FI. Scores could range from 0 (no symptoms) to 61 (very frequent FI). Values were computed from pre- and post- treatment questionnaires. (NCT00884832)
Timeframe: 4 weeks baseline, 4 weeks treatment
| Intervention | units on a scale (Mean) | |
|---|---|---|
| 4 weeks baseline | 4 weeks treatment | |
| Oral Clonidine | 36.2 | 29.3 |
| Oral Placebo | 37.3 | 31.2 |
Rectal urgency is defined as a sudden, irresistible need to have a bowel movement. Scores were averaged over the 4 week baseline period and the 4 week treatment periods. (NCT00884832)
Timeframe: 4 weeks baseline, 4 weeks treatment
| Intervention | percentage of bowel movements (Mean) | |
|---|---|---|
| 4 weeks baseline | 4 weeks treatment | |
| Oral Clonidine | 55 | 46 |
| Oral Placebo | 59 | 46 |
The percentage of bowel movements with semi-formed and loose stools was defined as those with a score of 5-7 on the Bristol stool form scale. (NCT00884832)
Timeframe: 4 weeks baseline, 4 weeks treatment
| Intervention | percentage of bowel movements (Mean) | |||
|---|---|---|---|---|
| 4 weeks baseline, subjects without diarrhea | 4 weeks baseline, subjects with diarrhea | 4 weeks treatment, subjects without diarrhea | 4 weeks treatment, subjects with diarrhea | |
| Oral Clonidine | 19.4 | 47.5 | 14 | 31.2 |
| Oral Placebo | 25.5 | 51.6 | 16 | 49 |
"The percentage of bowel movements with semi-formed and loose stools was defined as those with a score of 5-7 on the Bristol stool form scale. The adjustment for baseline was an analysis of covariance (ANCOVA) where the covariate was the baseline version of the endpoint." (NCT00884832)
Timeframe: 4 weeks treatment
| Intervention | percentage of bowel movements (Mean) | |
|---|---|---|
| Subjects with diarrhea | Subjects without diarrhea | |
| Oral Clonidine | 23.6 | 25.4 |
| Oral Placebo | 38.7 | 22.8 |
(NCT00884832)
Timeframe: 4 weeks baseline, 4 weeks treatment
| Intervention | percentage of days (Mean) | |||
|---|---|---|---|---|
| 4 weeks baseline, subjects without diarrhea | 4 weeks baseline, subjects with diarrhea | 4 weeks treatment, subjects without diarrhea | 4 weeks treatment, subjects with diarrhea | |
| Oral Clonidine | 28.7 | 35.4 | 23.2 | 24.3 |
| Oral Placebo | 37.8 | 42.1 | 18.7 | 33.3 |
"The adjustment for baseline was an analysis of covariance (ANCOVA) where the covariate was the baseline version of the endpoint." (NCT00884832)
Timeframe: 4 weeks treatment
| Intervention | percentage of days (Mean) | |
|---|---|---|
| Subjects without diarrhea | Subjects with diarrhea | |
| Oral Clonidine | 42.54 | 27.79 |
| Oral Placebo | 31.42 | 39.51 |
"This parameter was determined by a 100 mm visual analog scale, with possible scores ranging from 0 = Not satisfied at all (no relief of symptoms) to 100 = Completely satisfied (symptoms resolved). The parameter was computed from weekly diaries. Scores were averaged over the 4 week baseline period and the 4 week treatment periods." (NCT00884832)
Timeframe: 4 weeks baseline, 4 week treatment
| Intervention | units on a scale (Mean) | |
|---|---|---|
| 4 weeks baseline | 4 weeks treatment | |
| Oral Clonidine | 22 | 47 |
| Oral Placebo | 18 | 38 |
4 trials available for clonidine and Fecal Incontinence
| Article | Year |
|---|---|
A pharmacological challenge predicts reversible rectal sensorimotor dysfunctions in women with fecal incontinence.
Topics: Adrenergic alpha-2 Receptor Agonists; Adult; Atropine; Clonidine; Double-Blind Method; Fecal Inconti | 2018 |
Effects of clonidine in women with fecal incontinence.
Topics: Administration, Oral; Adolescent; Adrenergic alpha-2 Receptor Agonists; Aged; Anal Canal; Clonidine; | 2014 |
Validating endpoints for therapeutic trials in fecal incontinence.
Topics: Clonidine; Double-Blind Method; Fecal Incontinence; Female; Humans; Middle Aged; Quality of Life; Se | 2016 |
The effects of clonidine on symptoms and anorectal sensorimotor function in women with faecal incontinence.
Topics: Clonidine; Defecation; Fecal Incontinence; Female; Humans; Middle Aged; Sensation; Severity of Illne | 2010 |
1 other study available for clonidine and Fecal Incontinence
| Article | Year |
|---|---|
Clonidine and botulinum toxin: a tale of two treatments.
Topics: Adrenergic alpha-2 Receptor Agonists; Clonidine; Fecal Incontinence; Female; Humans | 2014 |